Disposable Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Teleport XT Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DISPOSABLE THERMOMETER COVERS AND SHEATHS

FDA 510(k)

FDA Class 2 ·General Hospital

FOXTROT NC PTCA Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electronic Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pelvic Floor Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Syringe with Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Mobility Scooter (S-01); Mobility Scooter (S-02)

FDA 510(k)

FDA Class 2 ·Physical Medicine

IRENE Locking Compression Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Wireless Digital Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

Endotracheal Tube

FDA 510(k)

FDA Class 2 ·Anesthesiology

HYPER DLR

FDA 510(k)

FDA Class 2 ·Radiology

2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)

FDA 510(k)

FDA Class 2 ·Radiology

Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Verifine Safety Type Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital